Indicating device

ABSTRACT

An indicating device for use with a dispensing device that dispenses metered dosages of a medicament from a container having a valve moveable between an open and closed position. In a preferred embodiment, the container is reciprocally moveable within the housing along a longitudinal axis. The housing preferably has a well adapted to receive a valve stem and an exhaust port. The well communicates with the port such that the metered dosage of medicament is dispensed through the port when the valve is moved to the open position. An indicator assembly comprises an indicator member that includes dosage indicia visible to a user. In a preferred embodiment, the indicator assembly is provided in an indicator module. A method for dispensing measured dosages is also provided, along with a kit capable of being assembled as an inhalation device. A delivery system having a key member and a key entry passageway is also provided.

This application is a continuation-in-part of application Ser. No.09/008,184, filed Jan. 16, 1998, and entitled Aerosol Dispensing Device,the disclosure of which is hereby incorporated herein by reference. Nolicense, expressed or implied, is intended to be granted to applicationSer. No. 09/008,184, or any patents issuing therefrom, by reason of theincorporation by reference herein.

BACKGROUND

The present invention relates generally to an indicating device, and inparticular, to an indicating device for indicating the number of metereddosages of a substance, and in particular a medicament, that have beendispensed by, or remain in, a dispensing device.

Delivery systems, and in particular, dispensing devices, have beendeveloped that include a counting or dose indicating device to indicatethe number of metered doses of substance that have been dispensed fromthe delivery system, or to indicate the number of doses remainingtherein. For example, patients have certain conditions that can betreated with medicaments dispersed in an aerosol and administered to thepatient by inhalation. In one format, the aerosol and medicaments arecontained in a container, and dispensed in metered, or measured, dosageswith the dispensing device, which can include an actuator boot. In suchan arrangement, it can be important for the patient to be able toascertain the number of metered doses remaining in the container, eitherby an indication of the number remaining therein or by knowledge of thenumber already dispensed therefrom, such that the patient is not caughtunaware with an empty container when in need of the medicament. Thus, itmay be important for the dispensing device to provide an accurateindication of either the number of doses remaining in the container, orthe number of doses already dispensed therefrom.

Typically, a conventional aerosol container includes a body and a valvestem which can be depressed relative to the body so as to emit themetered dose of aerosol and medicament. The container is usuallysupplied with a predetermined number of metered doses, e.g., on theorder of about 200, such that the counting of the number of valve stemdepressions, and corresponding number of dispensed metered doses, can bedirectly correlated with the number of doses remaining in the container.

In operation, the container is typically received within a housing ofthe dispensing device, wherein the valve is brought into engagement witha support block in the housing. The user administers the medicament bymoving the container relative to the housing so as to depress the valvestem and internal valve and thereby release a metered dose, which istypically administered to the user through a port or mouthpieceextending from the housing. In an alternative delivery system, themetered dose can be first discharged into a chamber, and thereafteradministered to the patient. After the metered dose is discharged fromthe container, the valve stem, which is typically spring loaded, biasesthe container away from the support block so as to again move thecontainer relative to the housing. In this way, a metered dose ofmedicament is discharged by each cycle of linear reciprocal movement ofthe container relative to the housing.

Some dispensing devices have indicating devices that convert the linearreciprocal movement of the container relative to the housing into aone-way, or single-cycle, movement of an indicator, wherein theindicator identifies the relative fullness of the container, the numberof metered doses remaining therein or the number of doses alreadyadministered. Although these dispensing devices with indicators haveprovided the advantage of generally being able to keep track of thenumber of dosages, there remains room for improvement. For example,indicating devices of this nature may include complex moving parts whichcan be difficult to assemble and expensive to manufacture. Such devicesmay also be susceptible to counting inaccuracies due to theconfiguration of the indexing or mating parts, or require excessiveamounts of space within the housing to accommodate the relatively largeor numerous moving parts. Others still may impede or interfere with theairflow and medicament being dispensed from the inhalation device.Alternatively, some devices use electrical circuitry to count or recordthe dispersements. Such devices can be relatively expensive tomanufacture, however, and typically require a power source which may besusceptible to damage in various environments, such as moist conditions.

SUMMARY

Briefly stated, in one aspect the invention is directed to a dispensingdevice having an indicating device. The dispensing device dispensesmetered dosages of a substance from a container having a valve moveablebetween a closed position and an open position. The container dispensesa metered dosage when the valve, actuated by a valve stem, is moved tothe open position. In an exemplary embodiment, the dispensing deviceincludes a housing adapted to support the container reciprocallymoveable within the housing along a longitudinal axis. The housing has awell adapted to receive the valve stem and an exhaust port. The wellcommunicates with the port such that the metered dosage of substance isdispensed through the port when the valve stem is moved to the openposition.

In one embodiment of the indicating device, an indicator assemblyincludes a worm rotatably mounted in the housing about an axistransverse to the longitudinal axis and responsive to the movement ofthe reciprocal movement of the container within the housing such thatthe longitudinal movement of the container relative to the housingcauses the worm to rotate about its axis. An indicator member includesdosage indicia visible to a user and a circular gear mounted in thehousing about an axis transverse to the axis of the worm andnon-parallel to the longitudinal axis. The circular gear engages theworm.

In a preferred embodiment, the indicator assembly further includes aratchet wheel rotatably mounted in the housing and adapted to beresponsive to the reciprocal movement of the container relative to thehousing along the longitudinal axis. The ratchet wheel is connected tothe worm such that rotation of the ratchet causes the worm gear torotate about its axis. In addition, an actuator member including an armis preferably mounted within the housing and is adapted to move inresponse to the movement of the container and operably engage theratchet wheel so as to rotate the wheel in response to the longitudinalmovement of the container relative to the housing. Also in the preferredfirst embodiment, the indicator member includes an indicator wheelcoaxially mounted with the circular gear on an axle defining the axis ofrotation of the indicator member. The dosage indicia are applied to asurface of the indicator wheel.

In another embodiment of the indicating device, the housing comprises atleast one engagement member and the indicator assembly includes aplurality of indicator members, including at least a first and secondindicator member. The plurality of indicator members are coaxiallymounted in the housing. At least one of the first and second indicatormembers includes an advancement member, while at least the other of thefirst and second indicator members includes a plurality of teeth. Inoperation, the first indicator member is rotated relative to the secondindicator member such that the engagement member selectively engages andbiases the advancement member into operable engagement with at least oneof the plurality of teeth so as to rotate the second indicator member anincremental amount.

In a preferred embodiment, an actuator member is mounted in the housingand is responsive to the movement of the container. The actuator memberselectively engages at least one of the plurality of teeth on the firstindicator member so as to advance the first indicator member anincremental amount in response to the movement of the container relativeto said housing. A spring is preferably disposed in the housing to biasthe actuator member into engagement with the container.

In another aspect of the invention, the indicator assembly, includingthe ratchet wheel, worm, actuator member and indicator member of thefirst embodiment, are mounted within an indicator module which isadapted to be mounted within the dispenser housing. Similarly, withrespect to the second embodiment, the indicator assembly, including theplurality of indicator members, advancement member, spring and ratchetmember, are supported in the indicator module. The module preferablyincludes a first and second member which are joined to form an enclosureor housing, and which support any one or more of the ratchet wheel,worm, actuator member and indicator member of the first embodimenttherein, or the plurality of indicator members, advancement member,spring and actuator member of the second embodiment. In the secondembodiment, the engagement members are also preferably disposed in themodule housing.

In another aspect of the invention, a key member is mounted to one ofthe container and the housing and is shaped to be received in apassageway formed in the other of the housing and container.

In yet another aspect of the invention, a method is provided fordispensing measured dosages from the container. In one embodiment, themethod includes the steps of moving the container along the longitudinalaxis so as to move the valve stem, and valve, to the open positionwherein a metered dosage is discharged. The longitudinal movement of thecontainer within the housing causes the ratchet gear to rotate apredetermined angular amount, which, in turn, causes the worm to rotateabout its axis. The worm then engages the circular worm gear of theindicator member so as to rotate the worm gear about its axis.

Alternatively, in a second embodiment, the first indicator member isrotated a predetermined amount in response to the movement of the valvebetween a closed and open position, or vice versa. Upon a predeterminednumber of movements of the valve, the first indicator member causes thesecond indicator member to rotate a predetermined amount.

In another aspect of the invention, a method is provided for assemblinga dispenser comprising a housing, a container and an indicator module.

In yet another aspect of the invention, a kit includes componentscapable of being assembled as a dispensing device for dispensing metereddosages of a substance from a container. The kit includes a housing, acontainer having a plurality of metered dosages of the substance and anindicator module having an indicator member.

The present invention provides significant advantages over otherindicating devices. In particular, with respect to the first embodimentof the indicating device, the worm provides for a compact drivecomponent that does not occupy excess space within the housing.Moreover, the worm provides for high gear reduction ratios whilemaintaining a continuous engagement with the circular worm gear. Thecontinuous engagement of the worm and circular gear ensures that theaccuracy of the counting device is maintained, while simultaneouslysimplifying the manufacturing and assembly process.

The use of a circular gear having an axis non-parallel, and preferablytransverse or perpendicular to the longitudinal movement of thecontainer within the housing, also provides several advantages.Importantly, the gear can be easily mounted to the housing with aninexpensive and easy-to-install axle. Thus, the circular gear providesfor a compact single-cycle device that fits easily into the housing, andwhich maintains continuous engagement with the worm gear for improvedand accurate indexing of the indicator member. Moreover, the componentsare arranged so as to not interfere with or otherwise impede the airflow from the valve stem to the exhaust port of the housing. Inaddition, the indicator wheel, which is preferably coaxially mountedwith the worm gear, provides an ideal planar surface for displaying thedosage indicia. The indicia can be easily viewed by the user through theviewing window.

The second embodiment of the indicating device provides similaradvantages. In particular, the plurality of indicator members can bemounted in a compact arrangement to provide accuracy and reliabilityunder various operating conditions but which does not impede or obstructthe airflow to the user. Moreover, the various parts are relativelyinexpensive to manufacture and assemble. The indicia, which are visibleto the user through the viewing window, are easy to read and readilyaccessible to the user.

The indicator module, with any of the various embodiments of indicatingassemblies disposed therein, also presents several advantages. Inparticular, the self-contained unit can be separately manufactured andinstalled as needed in any number of conventional types of dispensingdevices with minimal modification thereof. Moreover, the module can beeasily installed without interfering with or otherwise impeding the airflow from the valve stem to the exhaust port and ultimately to the user.

The key member also presents several advantages. In particular,differently configured key members and passageways can be installedbetween containers holding different substances such as medicaments andcorresponding delivery system housings so as to prevent the user frominterchanging various containers and housings so as to thereby alter thenumber of doses being counted. The key member and passageway can alsoprevent a user from using the wrong delivery system for a particularcontainer having a particular substance, such as a medicament.

The present invention, together with further objects and advantages,will be best understood by reference to the following detaileddescription taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a dispensing device with a viewingwindow revealing dosage indicia.

FIG. 2 is a perspective view of one embodiment of the dispensing devicewith a portion of the housing cut away.

FIG. 3 is a perspective view of one embodiment of the indicatorassembly.

FIG. 4 is a perspective view of an alternative embodiment of thedispensing device.

FIG. 5 is a perspective view of the dispensing device shown in FIG. 4with a portion of the housing cut away.

FIG. 6 is a perspective view of a container, a dispenser housing and oneembodiment of an indicator module with a portion of the housing cutaway.

FIG. 7 is an exploded perspective view of a container, a dispenserhousing and one embodiment of the indicator module with a portion of thehousing cut away.

FIG. 8 is an exploded perspective view of one embodiment of theindicator module.

FIG. 9 is an exploded perspective view of the indicator module from theopposite side as shown in FIG. 8.

FIG. 10 is an exploded perspective view of a container, and analternative embodiment of the dispenser housing and the indicatormodule.

FIG. 11 is a perspective view of the alternative embodiment of theindicator module shown in FIG. 10.

FIG. 12 is a section cut of a housing and an indicator module mountedtherein.

FIG. 13 is a top view of one embodiment of the indicator module.

FIG. 14 is a rear view of the indicator module shown in FIG. 13.

FIG. 15 is a cross-sectional view of the indicator module taken alongline 15--15 of FIG. 13.

FIG. 16 is a cross-sectional view of the indicator module taken alongline 16--16 of FIG. 13.

FIG. 17 is a cross-sectional view of the indicator module taken alongline 17--17 of FIG. 13.

FIG. 18 is a cross-sectional view of the indicator module taken alongline 18--18 of FIG. 13.

FIG. 19 is a perspective view of an alternative embodiment of themodule.

FIG. 20 is a cross-sectional view of the indicator module taken alongline 20--20 of FIG. 14.

FIG. 21 is an exploded view of a container, a key member and anindicator module.

FIG. 22 is a top view of the key member.

FIG. 23 is a cross-sectional view of the key member taken along line23--23 of FIG. 22.

FIG. 24 is a perspective view of a container and an alternativeembodiment of the indicator module mounted in a dispenser housing with aportion of the housing cut away.

FIG. 25 is an exploded perspective view of an alternative embodiment ofan indicator module, key member and indicator assembly.

FIG. 26 is a top perspective view of a first member of one embodiment ofthe indicator module housing.

FIG. 27 is a bottom perspective view of the member shown in FIG. 26.

FIG. 28 is a perspective view of one embodiment of an indicator member.

FIG. 29 is an opposite perspective view of the indicator member shown inFIG. 28.

FIG. 30 is a top perspective view of a second member of one embodimentof the indicator module with an axle installed therein.

FIG. 31 is a perspective view of an actuator member.

FIG. 32 is a perspective view of a container with an alternativeembodiment of a key member installed thereon positioned above oneembodiment of an indicator module.

FIG. 33 is a perspective view of an alternative embodiment of the keymember.

FIG. 34 is an exploded perspective view of an alternative embodiment ofa key member being applied to a container.

FIG. 35 is a cross-sectional view of an indicator module showing anadvancement member of a first indicator member, an engagement member anda second indicator member.

FIG. 36 is a cross-sectional view of the advancement member of the firstindicator member as it is first engaged by the engagement member in theindicator module housing.

FIG. 37 is a cross-sectional view of the advancement member as it isbiased by the engagement member into engagement with the secondindicator member so as to rotate the second indicator member.

FIG. 38 is a cross-sectional view of the advancement member as it isreleased by the engagement member and disengages from the secondindicator member.

FIG. 39 is an exploded perspective view of an alternative embodiment ofan indicator module and indicator assembly.

FIG. 40 is an enlarged side view of an actuator member in a disengagedposition adjacent a first indicator member.

FIG. 41 is a side view of the actuator member engaging the firstindicator member with the non-return being biased outwardly.

FIG. 42 is a perspective side view of an alternative embodiment of anindicator member.

FIG. 43 is an opposite perspective side view of the indicator member ofFIG. 42.

FIG. 44 is a cross-sectional view of an advancement member on a firstindicator member, a second indicator member and an engagement member.

FIG. 45 is a cross-sectional view of the advancement member as it isfirst engaged by the engagement member.

FIG. 46 is a cross-sectional view of the advancement member as it isbiased by the engagement member into engagement with the indicatormember.

FIG. 47 is a cross-sectional view of the advancement member as it isfurther biased by the engagement member into engagement with the secondindicator member.

FIG. 48 is a perspective view of an alternative embodiment of anindicator assembly disposed on a lower member of the module housing.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

Referring to the drawings, and in particular FIGS. 1, 4, 6, 7 and 24, adelivery system, configured as a dispensing device, or dispenser, isshown as including a housing 10, or actuator boot, and a container 100disposed therein. The housing 10 has a longitudinally extending cavity12 shaped to receive the container. A top portion of the housing isgenerally open such that the container can be inserted in the housingthrough opening 14 and be installed therein with a bottom end 102 of thecontainer protruding from the housing and exposed to the user foractuation.

It should be understood that the term "delivery system," as used herein,is meant to include a system or apparatus for delivering a substancefrom a container, reservoir, or similar repository, to a user, andincludes but is not limited to the disclosed dispensing device, whichdelivers the substance to the user in the form of an aerosol that isinhaled by the user. The term "dispensing device," as used herein, ismeant to include devices that extrude, spray or otherwise feed out ordeliver a substance in convenient units, and includes, but is notlimited to, the disclosed inhalation device which delivers metereddosages of a substance in aerosol form for inhalation by the user.

The term "longitudinal" as used herein is intended to indicate thedirection of the reciprocal movement of the container relative to thehousing. The terms "top," "bottom," "upwardly" and "downwardly" areintended to indicate directions when viewing the inhalation devices asshown in the Figures, but with the understanding that the container isinverted such that the top surface thereof is located adjacent thebottom of the housing and vice versa.

As shown in FIGS. 5, 6 and 7, a cylindrical support block 16 having awell 18 is formed in a bottom portion 22 of the housing. An orifice 20penetrates the support block to communicate with a bottom portion of thewell. A mouthpiece 24, intended for insertion into the mouth of apatient, forms an exhaust port 26 that communicates with the orifice andwell. The mouthpiece 24 extends laterally from the housing so as tofacilitate insertion of the mouthpiece into the mouth of the patient.

The container 100 is formed as a cylindrical canister 104 having a 106hub disposed on a top surface 108 thereof. A valve stem 110 extendslongitudinally from the hub. The valve stem extends coaxially from thecanister and is biased outwardly therefrom by a spring (not shown)mounted within the canister. The container 100 is mounted in the housingby press fitting the valve stem 110 in the well 18 of the support block.It should be understood that the container can be configured in avariety of shapes and sizes, and that the substance contained thereincan be released by any number of valve systems that are well known inthe art. It should also be understood that the valve system can beactuated by a variety of actuators, including, but not limited to,various pumps, levers, actuator boots, buttons and the like. In suchembodiments, the valve system can be actuated by an actuator moveablerelative to the container and housing such that the container remainsstationary relative to the housing.

In a preferred embodiment, the container 100 is filled with a substancewhich is dispensed therefrom in specific metered doses by depressing ormoving the valve stem 110 from an extended closed position to adepressed open position, which in turn opens the valve or valve system.Preferably the substance is a medicament, although it should beunderstood that the container could be used to hold a variety ofnon-medicinal substances, including, but not limited to, variousliquids, foams or aerosols that can be delivered by various deliverysystems, and/or dispensing devices. A medicament is defined as asubstance that can be used in therapy, such as for various therapeutictreatments, including the treatment of diseases (e.g., respiratoryailments) and for the relief of pain, and should be understood toinclude medicines and medicinal substances in general. A single metereddose is dispensed from the container by each reciprocal, longitudinalmovement of the valve stem and attendant opening and closing of thevalve. The medicament is typically delivered to the user, or patient,through their mouth and/or nose in the form of an aerosol, spray orliquid.

In operation, the opening of the valve stem and valve is effected bymoving the container 100 reciprocally within the housing 10 along alongitudinal axis, defined by the valve stem and the reciprocal movementof the container, by depressing the exposed bottom end 102 of thecanister relative to the housing 10 so as to move the valve stem 110 tothe open position as it is supported within the well by the supportblock. Alternatively, an actuator can be moved to open the valve systemof the container, which can remain stationary with respect to asupporting housing, a cap and/or an indicating device mounted thereto.For example, the actuator can be attached to the end of the container inthe form of a pump device or the like.

Referring to FIGS. 5-7, as the valve stem is moved to the open position,the container dispenses a metered dose of the substance in aerosol formthrough the well 18 and orifice 20 and into the exhaust port. Thesubstance in aerosol form is then transmitted to the user through theexhaust port of the mouthpiece by way of either a self-generated orassisted airflow. Alternatively, metered doses of liquids and the likecan be dispensed from the container.

In other delivery systems, which may also include a dispensing device,the housing and holder for the container are attached to a componenthaving a chamber with an output end. Examples of these kinds of deliverysystems and dispensing devices are shown for example in U.S. Pat. No.5,012,803, issued May 7, 1991, and U.S. Pat. No. 4,460,412, issued Sep.11, 1984, the entire disclosures of which are hereby incorporated hereinby reference. (No license, expressed or implied, is intended to begranted to either of these patents by reason of the incorporation byreference herein.) In these kinds of delivery systems, the componenthaving the chamber can be adapted to receive the mouthpiece of thehousing, or it can be integrally connected with a holder supporting thecontainer. In either embodiment, the metered dose of substance,preferably a medicament, in aerosol is first dispensed from thecontainer into the chamber, and thereafter inhaled by the user.

In a preferred embodiment, the container 100 is intended to dispense apredetermined number of metered doses of substance. For example,conventional inhaler containers typically hold on the order of 100 to200 metered doses. In operation, it is important that the user be awareof the number of metered doses remaining in the container such that theuser is not caught unaware with an empty canister when in need of thesubstance, such as a medicament.

Now referring to FIGS. 2 and 3, a dispensing device, configured as anaerosol dispenser, is shown as including a housing, a container mountedtherein as described above and an indicator assembly. The indicatorassembly includes a ratchet gear 32 coaxially mounted with a worm 40 onan axle 42 in a lower portion of the housing. A plurality of teeth 34are formed about the periphery of the ratchet gear. The teeth 34 are cutor formed with a tapered surface 36 and engagement surface 38. In apreferred embodiment, the ratchet and worm are formed out of a harddurable plastic. It should be understood, however, that other materialssuch as metal would also work. The ratchet and worm can be made asseparate parts, or molded as a single integral member.

In a preferred embodiment, the axle 42 and worm 40 define an axis ofrotation transverse, or perpendicular, to the longitudinal axis definedby the valve stem and reciprocal movement of the container relative tothe housing. Opposite ends of the axle 42 are rotatably supported in thehousing.

Also as shown in FIGS. 2 and 3, an indicator member 50 comprises acircular worm gear 52 and indicator wheel 58 coaxially mounted on anaxle. In a preferred embodiment, the axle 56 defines an axis of rotationtransverse to the axis defined by the worm and also transverse to thelongitudinal axis defined by the reciprocal movement of the containerrelative to the housing. The axle 56 is rotatably supported in thehousing. Teeth 54 are formed around the periphery of the worm gear 52and are shaped to permanently engage the worm 40. As shown in FIG. 2,the indicator wheel 58 has a planar face 60 which is exposed to thepatient through a viewing window 28 formed in the housing.

The ratchet gear 32, worm 40, worm gear 52 and indicator wheel 58provide an ideal arrangement for indicating the number of dosesremaining in the container, or the number dispensed therefrom. Inparticular, relatively high reduction ratios are made possible throughuse of the ratchet, worm and worm gear without the correspondingrequirement of providing extremely fine teeth on one or more of theratchet gear and worm gear. Moreover, the worm and worm gear interfaceavoids the associated inaccuracies introduced by the mating, andpotential skipping, of conventional spur gears having fine teeth.Furthermore, the installation of the indicator member is effected by theinstallation of a simple axle which can be supported in a plurality ofpositions and angular orientations within the housing. Importantly, thehigh reduction ratio realized with the worm 40 allows for the worm gear52 to have a relatively small diameter, such that it can be easilymounted within small spaces within the housing. Indeed, as shown inFIGS. 6 and 12, the entire indicator assembly can be mounted behind thesupport block 16 and below the upper surface 17 thereof such that theassembly does not interfere with the dispensing of the medicament fromthe orifice or with the airflow generated by the patient inadministering the medicament.

Referring to FIG. 5, an actuator member 70 is configured as a postmember 72 moveably supported in the housing along an axis parallel tothe longitudinal axis defined by the reciprocal movement of thecontainer within the housing. In an alternative embodiment shown inFIGS. 7-9, the post member includes an upper portion 74, a middleportion 76 and a lower portion 78. A resilient arm member 80 extendsfrom the middle portion of the post member and terminates in a taperedhook member 82 shaped to selectively engage one of the ratchet wheelteeth. The middle portion 76 is defined by upper and lower stop surface84, 86. A spring 88 is disposed about the lower portion 78 of the postmember and engages the lower stop surface 86 so as to bias the actuatormember upwardly against the top surface 108 of the canister as shown inFIG. 7. Although a compression spring is shown in the Figures, it shouldbe understood that cantilever, torsion, leaf and tension springs, andthe like, would also work to bias the actuator member upwardly intoengagement with the container. The springs can be made of metal orplastic.

In an alternative embodiment, shown in FIGS. 2 and 3, actuator member 90includes locking ring 92 and a resilient arm member 94 extendinglongitudinally downwardly therefrom. A longitudinal slit 96 is formed inthe locking ring so as to allow for the locking ring 92 to be expandedand disposed around the hub 106 (shown in FIG. 5) of the canister in asnap fit configuration such that the valve stem of the container extendsthrough opening 98 of the locking ring. A distal end of the resilientarm member terminates in a hook member 95 which is shaped to selectivelyengage the teeth of the ratchet wheel.

In the operation of the embodiment shown in FIGS. 6-9, 13-18 and 20, thecontainer is moved longitudinally within the housing so as to depressthe valve stem to the open position so as to open the valve as explainedabove. As the container is moved downwardly within the housing, theactuator member 70 is moved longitudinally downward such that the hookmember 82 engages the ratchet wheel and rotates it a predeterminedangular amount corresponding to the pitch of the teeth. When thecontainer is released by the user, the spring (not shown) within thecontainer biases the container upwardly within the housing along thelongitudinal axis such that the valve stem 110 is moved to the closedposition within the container so as to close the valve. As the containermoves upwardly, the resilient arm member 80 is biased laterally outwardas a tapered end portion of the hook member 82 slides against thetapered surface 36 of one of the ratchet teeth. As the container andresilient arm member reach the top of the stroke, wherein the valve stemis moved completely to the closed position, the resilient arm member 80returns to its normal straightened configuration as the hook member 82slips past the tapered surface of one of the teeth so as to bepositioned over the engagement surface 38 of that tooth 34 for the nextcycle.

Alternatively, the operation of the ratchet wheel can be reversed asshown in FIG. 3. In this embodiment, the resilient arm member 94 isbiased outwardly by the tapered surface of one of the ratchet gear teethon the downstroke. At the bottom of the stroke, the hook member 95 slipsinto an underlying relationship with the engagement surface of thetooth. When the container is released by the user, the spring (notshown) within the canister biases the container upwardly within thehousing along the longitudinal axis such that the valve stem is moved tothe closed position within the container. As the container movesupwardly with respect to the housing, the resilient arm member 94 moveslongitudinally upward such that the hook member 95 engages theengagement surface 38 of one of the teeth and thereby rotates theratchet wheel an incremental amount.

In the embodiment shown in FIGS. 6-9, 13-18 and 20, it is the force ofthe spring 88 that moves the arm member 80 upwardly so as to return theactuator member in preparation for another cycle. In the alternativeembodiment shown in FIGS. 2 and 3, it is the movement of the container,as it is biased upwardly by the internal spring acting on the valvestem, that causes the locking ring 92 and arm member 94 to move upwardlyand thereby rotate the ratchet gear.

Referring to FIGS. 8 and 17, a resilient non-return member 200 engagesthe ratchet gear adjacent the hook member so as to ensure that therotation of the ratchet gear is unidirectional. Alternatively, thenon-return member can be positioned to engage the ratchet gear oppositethe actuator arm member. The non-return member includes an end portionadapted to engage the engagement surface of the ratchet gear teeth. Asthe ratchet gear is rotated by the actuator, the non-return memberslides along the tapered surface of one of the teeth of the ratchetwheel and does not interfere with the rotation thereof.

The rotation of the ratchet gear causes the worm 40 to rotate a desiredpredetermined amount. It should be understood that the desired amount ofrotation is dependent upon the diameter of the ratchet wheel and thenumber of teeth positioned thereabout. Rotation of the worm, whichpermanently engages the teeth of the worm gear, causes the worm gear andindicator wheel to rotate a predetermined incremental amount. The amountof rotation of the indicator wheel is dependent upon the pitch of theworm, the number of worm threads and the pitch of the worm gear and thenumber of worm gear teeth. In a preferred embodiment, the worm has asingle thread.

For ease of manufacturing, it is desirable to provide as coarse a pitchon each of the ratchet and worm gears as possible, although the gearsare still defined as fine-toothed gears. However, it is also intendedthat the indicator member make only a single revolution (single-cycle)corresponding to a complete evacuation of medicament from the container.Thus, when a large number of doses (on the order of 200 or more) arecontained within the canister, it is important for the ratchet, worm andworm gear to provide a relatively high reduction ratio, such that 200linear reciprocal movements of the actuator member correspond to one orless revolutions of the indicator member. Because the ratchet gear andworm rotate together, it should be understood that the number of teethon the ratchet gear and worm gear, and the number of threads of theworm, determine the ultimate reduction ratio between the rotation of theratchet gear and the rotation of the indicator wheel.

For example, when the container holds 240 metered doses, an acceptableratio is realized if the ratchet is made relatively coarse with 10 teethand the worm gear is provided with 28 teeth. In operation, thedispensing of 10 metered doses will cause the worm to make one completerevolution so as to thereby move the worm gear one tooth. After 240linear reciprocal movements, the worm gear has been advanced by 24teeth. Extra teeth are provided so that the starting and ending indicia,indicating a relative fullness or emptiness of the containerrespectively, are not labeled one on top of the other.

In a preferred embodiment, shown in FIGS. 9 and 15, the worm gear 52 hasteeth formed around only a portion of its periphery so that a gap isformed between the teeth around the remaining portion of the periphery.In operation, the gears are configured so that the worm 40 disengagesfrom the last tooth of the worm gear as the final prescribed dose ofmedicament is dispensed. In this position, the indicia on the indicatorwheel 58 will indicate to the user that the canister is empty.Therefore, although the user can continue to move the container so as toopen the valve, the resultant movement of the actuator 70, ratchet gear32 and worm will not in turn rotate the indicator member as the gap inthe teeth on the worm gear results in the disengagement of the worm andworm gear. In this way, the indicator wheel is prevented from beinginadvertently rotated from a full to empty reading and then back againto a full reading, which could confuse the user about the number ofdoses remaining in the canister.

The indicator wheel 58, indicia 66 and viewing window 28 can be arrangedin a variety of configurations for viewing by the user. For example, theviewing window 28, 124 can be configured as a rectangular shaped windowas shown in FIG. 2 or 10 respectively, as an arcuate shaped window 29 asshown in FIG. 4, wherein approximately 1/3 of the face of the indicatorwheel is visible at any time, as a circular shaped window (not shown) oras any other shape allowing the user to view the indicator wheel and theindicia located thereon. In one embodiment, the indicia take the form ofa color code, where, for example, a portion of the wheel is coloredgreen to indicate the starting full position, a portion is coloredyellow to indicate a medium fullness and a portion is colored red toindicate that the container is empty. Obviously, other colors, shadingor alpha-numerical indicia can be provided on the indicator wheel toindicate the relative fullness or emptiness of the container.

In an alternative embodiment, the indicator wheel can be oriented withinthe housing such that either its planar face or its circumferentialsurface, with indicia applied thereto, are visible to the user throughthe exhaust port of the mouthpiece.

Referring to FIG. 25, an alternative embodiment of an indicator assemblyis shown. The indicator assembly includes three indicator members 550coaxially mounted on an axle 556 and rotatable thereabout. As best shownin FIGS. 28 and 29, each of the indicator members includes an indicatorwheel 558 having a circumferential skirt 559 with an outercircumferential surface 560 on which indicia (shown as numbers) areapplied, and a ratchet gear 552 coaxially mounted with the indicatorwheel. The indicator wheel and ratchet gear have an opening 553 shapedto receive the axle. The ratchet gear 552 includes a plurality of teeth554 formed around its periphery. The ratchet gear is preferablyintegrally molded with the indicator wheel, although it should beunderstood that the gear and wheel can be made separately and thereafterattached one to the other by welding, adhesive and the like.

In one embodiment of the indicator member, a resilient advancementmember 600 is formed from a portion of the circumferential skirt 559 byproviding an elongated cutout 602 in the indicator wheel radially inwardfrom and beneath the skirt. The advancement member 600 includes alaterally extending tooth portion 604 having an engagement surface 606.The three indicator members are coaxially mounted such that the toothportion 604 of the advancement member of a first indicator memberoverlies the ratchet gear teeth 554 of the second indicator member, andsuch that the tooth portion 604 of the advancement member of the secondindicator member overlies the ratchet gear teeth 554 of the thirdindicator member. When only three indicator members are used (as shownin FIG. 25), the third indicator member does not require an advancementmember, although for the sake of simplicity in manufacturing, a modularindicator member with the same indicia applied thereto and the sameadvancement member formed thereon is preferably used for each of thefirst, second and third indicator members. It should be understood byone of skill in the art that one or more indicator members may be usedto provide an indication of dosages used or available, and that thethree indicator members shown in the Figures is meant to beillustrative, rather than limiting. In addition, it should be understoodthat a plurality of indicator members refers to any number of indicatormembers greater than one.

In an alternative embodiment of the indicator member 650, shown in FIGS.39, 42 and 43, an advancement member 800 is disposed radially inwardfrom a circumferential skirt 659 and includes a first end 657 connectedto a planar side portion or hub 655 of the indicator wheel. Theadvancement member includes a curved resilient portion 708 having a freeend with a tooth portion 704 extending laterally outward therefrom so asto extend laterally from beneath the skirt 659 of the indicator wheelsuch that it overlies the teeth of the ratchet gear of an adjacentindicator member coaxially mounted therewith as shown in FIG. 48.Indicia, preferably in the form of numbers, are applied to thecircumferential surface 660 of the skirt. A ratchet gear 652, having aplurality of teeth 654 is coaxially mounted with the indicator wheel. Asshown in FIG. 48, three indicator members are coaxially mounted on axle656.

Referring to FIGS. 25 and 39, an actuator member 570, 670, otherwisereferred to as a ratchet member, is shown as having an upper portion574, 674 extending upwardly from a lower portion 578, 678 and aresilient arm member 580, 680 extending outwardly therefrom andterminating in a resilient hook member 582, 682 shaped to selectivelyengage at least one of the teeth of the ratchet gear of the firstindicator member. A spring 588, 688 is disposed around the lower portionof the actuator member and biases the upper portion 574, 674 of theactuator member into engagement with the container.

Referring to FIG. 27, a housing 820 is shown as having a pair ofengagement members 770 formed integrally with the housing and includingramped surfaces 772. A plurality of non-return members 900 extend fromthe housing and selectively engage the ratchet gear to ensureunidirectional rotation of the indicator member as shown in FIGS. 35-38.Although the engagement members and non-return members are shown asbeing formed in or extending from a module housing, as described below,one of skill in the art should understand that those members orequivalent features could also be formed in or connected to thedispenser housing or actuator boot that supports the container, ordisposed on or connected to the container itself.

Referring to FIGS. 25 and 35-38, the operation of the indicator assemblyshown in FIG. 25 is generally shown. In particular, the container ismoved longitudinally within the housing 10 so as to depress the valvestem 110 to the open position so as to open the valve as explainedabove. As the container is moved downwardly within the housing, ordownwardly with respect to the module housing described below, theactuator member 570 is moved longitudinally downward such that the hookmember 582 is biased outwardly by the ratchet gear 552 on a first outerindicator member. At the bottom of the stroke, the hook member 582 slipsinto an underlying relationship with the teeth on the ratchet gear. Whenthe container is released by the user, the spring (not shown) within thecontainer biases the container upwardly within the housing along thelongitudinal axis such that the valve stem 110 and valve are moved tothe closed position within the container. As the container movesupwardly, the resilient arm member 580 moves longitudinally upward suchthat the hook member 582 rotates the first indicator member apredetermined angular or incremented amount corresponding to the pitchof the teeth disposed around the periphery of the ratchet gear. As thecontainer and resilient arm member reach the top of the stroke, whereinthe valve stem and valve are moved completely to the closed position,the resilient arm member 580 is positioned over the ratchet gear for thenext cycle. Alternatively, the operation of the actuator member andratchet gear can be reversed as explained above with respect to theembodiment shown in FIGS. 6-9.

Referring to FIGS. 39-41 and 44-48, a plurality of resilient arm members700 are shown as extending from a module housing so as to be alignedwith the ratchet gears on each of the indicator members. The arm members700 each serve as a combined engagement member and non-return member. Inparticular, as shown in FIGS. 40 and 41, the arm member 700 functions asa non-return member and includes an end portion that is biased away fromthe teeth on the ratchet gear as the actuator member, or adjacentindicator member with its advancement member, is actuated to advance theratchet gear. The operation of the actuator member 670 and ratchet gearis similar to the operation of the ratchet gear shown in FIGS. 6-9 asexplained above. The arm member 700 snaps back so that the end portionengages one of the teeth of the ratchet gear so as to ensure that therotation of the ratchet gear is unidirectional. As shown in FIGS. 44-47,the arm member 700 overlying the ratchet gears of the second and thirdindicator members also serves as an engagement member that selectivelyengages the advancement members connected to the indicator members.

In operation, the reciprocal movement of the container relative to thehousing is repeated until the first indicator member 550, 650, and itsratchet gear, are rotated one complete revolution. The predeterminednumber of reciprocal movements required to advance the first indicatormember one revolution is equal to the number of teeth disposed about theperiphery of the ratchet gear 552, 652. As the first indicator member isrotated by successive movements of the container relative to thehousing, the advancement member 600, 800 of the first indicator memberis brought into selective engagement with the engagement member,configured as the ramped surface 772 formed in the housing or as theupwardly extending arm member 700. In particular, the engagement member700, 772 biases the tooth portion 604, 704 of the advancement memberinto engagement with one of the teeth 554, 654 of the ratchet gear onthe second indicator member.

As the first indicator member is further rotated by successive movementsof the container relative to the housing, whether it be the dispenserhousing for the container or the module housing described below, theadvancement member 600 engages one of the teeth on the ratchet wheel ofthe adjacent indicator member and advances the indicator member apredetermined incremental angular amount corresponding to the pitch ofthe ratchet gear teeth. The term incremental is meant to refer to theangular amount the indicator member is moved by the advancement of oneactuation, which corresponds to the movement of one tooth, regardless ofwhether the indicating device is indicating the number of doses left(e.g., counting down) or indicating the number of doses administered(e.g., counting up).

As the resilient advancement member 600, 800 clears the engagementmember 772, 700, it springs away from the ratchet gear such that furtheradvancements of the first indicator member do not effect a rotation ofthe second indicator member until the first indicator member completesyet another cycle so as to again bring the advancement member intoengagement with the next tooth of the second indicator member ratchetgear, and so on. The second indicator member 550, 650 with itsadvancement member 600, 800, similarly interacts with a secondengagement member overlying the teeth of the third indicator member soas to selectively engage and advance the third indicator member apredetermined incremental amount for each complete rotation of thesecond indicator member. It should be understood that more indicatormembers could be similarly assembled to provide an incrementalindicating device.

In a preferred embodiment of the dispensing device, shown in FIGS. 6-10,13-18, 20, 24, 25 and 39, the indicator assembly is arranged in anindicator module 120, 1020, 1120. The indicator module 120, 1020, 1120is shaped to be received within the housing where it is disposed arounda portion of the support block 16. In particular, the support block isspaced apart from the wall of the dispenser housing, otherwise referredto as the actuator boot, so as to form a donut-shaped socket in thebottom of the housing. The module includes a module housing 130, 1030,1130 having an inner concave surface 132, 1032, 1132 that is shaped tomate with an outer convex surface of the cylindrical support block andan outer convex 134, 1034, 1134 surface that is shaped to mate with theinner concave surface of the housing which is also generallycylindrical. In this way, the module housing is shaped to be receivedwithin the socket formed around the support block. Preferably, themodule housing has a semicircular shape and fits around a portion of thesupport block opposite the orifice opening so as to not interfere withthe dispensing of the medicament, or the airflow transmitting themedicament to the patient. In this way, the module is maintainedrearwardly of the midpoint of the support block. One of skill in the artshould understand, however, that the module, or module housing, can beconfigured in any number of different sizes and shapes so as to beaccommodated in a variety of housings or cap assemblies, with or withoutsupport blocks and the like.

As shown in FIGS. 8-9, one embodiment of the module preferably includesa face portion 210 that extends from the rear convex surface of themodule and includes a module viewing window 64. The face portion snapsinto the housing viewing window opening (circular opening not shown) soas to secure the module thereto. As shown in an alternative embodimentin FIGS. 10-12, the face portion includes a vertically orientedrectangular viewing window 68 and a downwardly extending locking member122 which extends through the dispenser viewing window opening 124 andengages a bottom wall of the housing. In yet other embodiments, shownfor example in FIGS. 24 and 30, the face portion 1031, 1131 and viewingwindow 1064, 1164 have an elongated horizontal orientation so as toprovide the user with a view of the plurality of indicator membersmounted within the module. It should be understood, however, that themodule can be secured within the housing by any number of conventionalmeans, including the use of fasteners or adhesive. Alternatively, themodule can simply be press fit into the socket formed between thesupport block and housing wall.

In the embodiment shown in FIG. 8, the circular viewing window 64 isprovided in the module housing so as to expose a substantial portion ofthe planar indicator wheel. Numerical indicia, corresponding to thenumber of doses in the container, are provided on the face 60 of theindicator wheel. An arrow, or like indicator, is applied to the housingadjacent the viewing window and provides an indication of the number ofdoses remaining in the housing, or the number dispensed therefrom, asthe indicator wheel is rotated.

In other alternative embodiments, shown for example in FIGS. 10, 11, 25and 39, the indicia are applied to a circumferential surface 62, 560,660 of the indicator wheel. The module viewing window 68, 1064, 1164,which is preferably rectangular, and indicator wheel are arranged suchthat the circumference, or periphery, of the wheel, or wheels, isvisible through the module and dispenser viewing windows. As with theother embodiments, the indicia can take the form of color coding,shading, alpha-numerical characters and the like.

In the embodiments shown in FIGS. 28-29 and 42-43, the indicia arepreferably formed around the circumferential surface 560, 660 of theindicator wheel in the form of numbers ranging from 0 to 9, with theratchet gear on the indicator member having 10 teeth. In operation, itshould be understood that the three, or more or less, indicator memberscan be preset to the maximum number of dosages contained within thecontainer, with the indicia, or in this case numbers, arranged about theperiphery of the indicator wheel, such that successive, sequentialactuations of the container cause the indicator members to count down.

Alternatively, the indicator members are assembled such that the zero(0) of each indicator member is displayed in the viewing window to theuser. The container is then actuated by the user such that the firstindicator member rotates within the housing to sequentially display thenumber of doses that have been dispensed from 1 to 9. Upon the tenthactuation, the indicator member completes a single revolution, by virtueof the ten teeth preferably formed about the ratchet gear whichcorrespond to the predetermined number of actuations, and causes thesecond indicator member to advance one number from 0 to 1 as the firstindicator member again displays a 0 such that the two members togetherindicate that 10 dosages have been dispensed. The first indicator memberis again rotated by successive actuations until another single rotationis completed to further rotate the second indicator to reveal the 2, soas to indicate that 20 dosages have been dispensed. Upon a completerotation of the second indicator member, corresponding to 100actuations, the third indicator member is advanced to reveal a 1 in theviewing window with the first and second indicator members revealing a0, and so on.

As shown in FIGS. 6-10, 13-18 and 20, one embodiment of the indicatorassembly, including the worm, worm gear, ratchet gear and indicatormember, is mounted within the module housing 130. Similarly, theembodiments of the indicator assembly shown in FIGS. 25 and 39 are alsopreferably supported in a module housing 1030, 1130. The module housingis preferably formed from a first and second cover member 136, 138,1036, 1038, 1136, 1138 although it should be understood that a single,integral piece of material would also work, as would any plurality ofmembers joined together. Referring to FIGS. 6-10, 30 and 39 the firstcover member 136, 1136, 1036 has a vertical wall 140, 1140, 1040defining at least a portion of the outer convex surface 134, 1034, 1134shaped to mate with the inner surface of the housing as described above.The secondary viewing window 64, 1064, 1164 of the module is provided inthe vertical wall 140, 1040, 1140 so as to be aligned with the viewingwindow of the housing when the module is installed therein. The viewingwindow is framed by the face portion. In one embodiment, shown in FIG.9, the first member also includes a pair of opposing bearing seats 144formed on an inner surface of the vertical wall. The bearing seats 144are shaped to support the ends of axle 42. Alternatively, as shown inFIGS. 27 and 30 a bearing seat or lug 1044 can be formed on each of thefirst and second cover members. As best shown in FIGS. 9 and 30, a postmember 146, 1046 extends upwardly from a base 150, 1050 of the firstmember adjacent one of the bearing seats and has a socket 148, 1048formed coaxially therein. Alternatively, as best shown in FIG. 39, thebase 1150 is formed as part of the second cover member and includes anopening 1148 shaped to receive the lower portion 678 of the actuatormember.

Referring to FIGS. 8-9, the second cover member 138, 1038, 1138 mateswith the first cover 136, 1036, 1136 to form an enclosure therebetween.The second cover member includes a vertical wall 152, 1052, 1152, aportion of which defines the concave surface 132, 1032, 1132 shaped tomate with the outer surface of the support block. An upper horizontalflange 154, 1054, 1154 extends from the vertical wall 152, 1052, 1152and mates with the vertical wall of the second member in overlyingrelationship therewith so as to close off the top of the module. In analternate embodiment, the upper flange 1154 is formed as part of thefirst cover member. The upper flange 154, 1054, 1154 has an opening 156,1056, 1156 formed therein which is shaped to receive the upper portion74, 574, 674 of the post member. In one embodiment, the upper surface ofthe flange is maintained parallel with or below the top surface of thesupport block so as not to interfere with the container as it isdepressed toward the support block. Alternatively, as shown in FIGS. 8and 9, the module housing is provided with a semi-circular recess 155shaped to receive the hub as the container is actuated whereby thesurface 108 of the container engages the upper portion 74 of theactuator member and the surface 108 is positioned adjacent to thesurface 154 of the module housing when the valve is moved to the openposition. A bottom edge 158 of the vertical wall mates with the base 150of the first cover member to close off the bottom of the module. Asshown in FIGS. 8-9, 25-27 and 30, the cover members are joined byslidably engaging vertical flanges 160, 1060 on the first cover memberwith grooves 162, 1062 formed on the second cover member. Inwardlyextending tabs 220, 1061 snap fit into slots 222, 1063 formed in thesecond cover member. In the embodiment shown in FIGS. 26, 27 and 30, atab member 1067 engages opening 1071 formed in a wall member 1069 thatfurther defines a portion of the outer concave surface of the modulehousing. Alternatively, it should be understood that the first andsecond cover members can be joined with fasteners, adhesive and thelike.

As best shown in FIGS. 7, 15, 32 and 48, when the cover members areassembled to form the module housing, the upper portion 74, 574, 674 ofthe post member extends through the opening in the upper flange of thefirst cover member and engages the top surface 108 of the container,which is inverted in the housing. Alternatively, the actuator member canbe attached to the hub of the container with the locking ring aspreviously described. In such an embodiment, the arm member of theactuator member extends downwardly from the ring through the opening inthe top of the first cover member and is positioned to selectivelyengage the ratchet gear. The insertion of the arm in the openingprevents the canister and attached locking ring from being rotated so asto move the arm member out of position for selective engagement with theratchet gear.

As best shown in FIGS. 9 and 25, the lower portion 78, 578 of the postmember is moveably received within the socket 148, 1048 formed in thepost member 146, 1040 extending from the base of the second covermember. Alternatively, the lower portion 678 is received in the opening1148 as shown in FIG. 39. Referring to FIGS. 9, 25 and 39, spring 88,588, 688 is disposed about the lower portion 78, 578, 678, and incertain embodiments includes a lower end mounted on the post member 146,1046. The upper end of the spring engages the lower stop surface 86,586, 686 of the post member 72, 572, 672. The spring biases the postmember upwardly within the housing such that the upper portion 74, 574,674 protrudes through the opening and into engagement with the topsurface of the container 108.

In one embodiment, shown in FIGS. 8 and 9, the worm 40 and ratchet gear32 are rotatably supported on the bearing seats 144 formed in the secondmember. Preferably, opposite ends of axle 42 are snap fitted into thebearing seats. The indicator member 50 is rotatably supported by thesecond cover member such that the worm gear engages the worm when thecover members are joined together. In particular, the second coverincludes a pair of downwardly opening lug members 164, 166. The axle 56of the indicator member is received in the first lug member 164 and ahub portion 59 positioned between the worm gear and the indicator wheelis received within the second lug member 166. Preferably, the axle andhub are snap fitted into the lugs, but are permitted to freely rotatetherein. When the cover members are joined, the indicator member, and inparticular the worm gear, are trapped between the lug members and theworm.

In an alternative embodiment shown in FIGS. 25-27 and 30, the axle 556is supported on opposite ends by the lug portion 1044 extending fromeach of an upper and lower cover members 1036, 1038. The axle 556 has aT-shaped cross-section formed as a result of a molding process, e.g.,when the axle is integrally formed or molded with one or more of themodule housing cover members. The shape of the axle also permits it toact as a key member when received in similarly shaped sockets formed inone or more of the lug portions. The axle extends outwardly from the lugportion. The axle includes opposite curved surfaces 555, 557, as bestshown in FIGS. 35-38 that provide a supporting surface for the indicatormembers that are rotatably mounted thereon. One of skill in the artshould understand that the axle could have a circular cross-section andcould be rotatably mounted to the housing. In such an embodiment, atleast one of the indicator members can be integrally formed with theaxle, or all of the member can be separately mounted thereon.

It should be understood that in the alternative embodiment of FIGS. 2-5,the supporting structure for the worm and ratchet, including the bearingseats or like supports, and the supporting structure for the indicatormember, including the lug members, are similar to the structure providedin the module housing, but are integrally molded into the housing.Similarly, a post and socket member can be integrally molded into thebottom of the dispenser housing so as to support the actuator member andspring.

Similarly, although the indicator assembly embodiments of FIGS. 25 and39 are shown as preferably being mounted in the indicator module, one ofskill in the art should understand that the assembly, including theaxle, indicator members, actuator member and spring could be mounteddirectly in the dispenser housing or actuator boot that supports thecontainer. Similarly, the engagement member, or members, and non-returnmember, or members, could be formed in the dispenser housing thatsupports the container, otherwise referred to as the actuator boot.

In an alternative embodiment shown in FIG. 19, a lower portion 172 ofthe outer vertical wall of the module housing is angled so as to a matewith a housing having a similar angled planar bottom surface. As shownin FIG. 19, the axis of rotation of the indicator member is oriented atan angle of approximately 45 degrees from the longitudinal axis so thatthe face of the indicator wheel 60 is substantially parallel to theangled surface of the housing. A viewing window is provided in theangled surface 172 and is aligned with a similar viewing window providedin the angled wall of the dispenser housing.

Now referring to FIGS. 21-23, a key member 300 is shown as including abase portion 302 having a recess 304 shaped to receive the top of thecontainer. The base portion is circular shaped and is open in themiddle. The key member is mounted on the container by press fitting acircumferential flange 306, which forms the recess, about the containersuch that the valve stem and hub passes through an opening 308 formed inthe middle of the key member. Alternatively, the key member can bemounted to the container with adhesive or other fasteners. The keymember also includes a key portion 310 extending downwardly from thebase portion. The key portion is preferably configured as a circularflange member, although other shapes would also work.

In alternative embodiments shown in FIGS. 25 and 32-33, the key member1300 includes a mounting portion 1302, configured as a hoop memberhaving a plurality of ribbed portions 1304. The mounting member 1302 issized to fit over the end of the container such that the ribbed portionsgrip a portion of the container. A plurality of arm members 1306 securea key portion 1308 to the mounting member.

In another alternative embodiment shown in FIG. 34, the mounting member1402 has a smaller diameter than the key portion, and is coaxiallydisposed with the key portion. A base member 1404 connects the mountingmember and key portion. The mounting member includes a plurality ofinwardly facing tab members 1410 that engage an outer tapered surface ofthe hub portion 106 of the container.

In the embodiments shown in FIGS. 25 and 34, the key portion 1308, 1408is formed as a circular flange member having a plurality of openings1312, 1412 formed therein about the circumference thereof so as to allowair to flow through the key member with less restriction. In theembodiment shown in FIGS. 32 and 33, the key portion 1508 includes twocoaxially mounted key portions of different diameters, each with aplurality of openings 1512 to facilitate air flow therethrough.

The embodiment of the indicator module shown in FIG. 21 has a key entrypassageway configured as a recess 312 formed in an upper surface of themodule housing. Preferably, in this embodiment, the recess is formed asan arcuate shaped, or semi-circular, slot. The actuator member 314extends upwardly from the module housing into the slot. The actuatormember 314 is maintained substantially flush with or below the uppersurface of the module 316. In this way, the actuator cannot be actuatedby a user's finger or the like so as to inadvertently advance theindicator member and thereby provide an inaccurate reading of the numberof dosages remaining in the container, or the number dispensedtherefrom.

The shape or diameter of the key portion and corresponding entrypassageway are configured so that the key portion communicates with andis received in the passageway formed in the module housing. When thecontainer is mounted in the dispenser housing such that the valve stemis received in the well in the support block, the key portion isreceived in the passageway and engages the actuator member.

In an alternative embodiment of the dispensing device, with or withoutan indicator module or indicator assembly, a key entry passageway can beformed directly in the dispenser housing, e.g., in a bottom portion ofthe dispenser housing, wherein it receives a key portion disposed on thecontainer. It should be understood that the term "housing," as usedherein, can refer to the dispenser housing, the indicator modulehousing, or a combination of those housings.

In yet another alternative embodiment, the key portion and key entrypassageway are reversed. In this embodiment, the key portion is formedon the housing, i.e., the indicator module housing, or the dispenserhousing if the dispensing device lacks an indicator module and/or anindicator assembly, and the key entry passageway is formed in thecontainer. For example, the module housing, or dispenser housing, caninclude a ring member that is received in a ring-shaped recess formed inthe hub of the container. Or, the dispenser housing or module housingcan be configured to include one or more protuberances that are receivedin one or more recesses formed in the container.

In this way, key members having differently shaped key portions can beapplied to containers holding different types of substances, such as amedicament, so as to prevent the user from mixing up the containers anddispensers. In operation, a container having a certain key member with aspecific key portion can be installed only in a dispenser housing havinga passageway shaped to receive that key portion. If the key portion doesnot fit the recess, the key ring will engage the upper surface of themodule housing so as to prevent the actuation of the container relativeto the dispenser housing and the attendant opening of the valve. This inturn prevents a user from installing containers having differentsubstances in different dispensers, which could thereby adversely affectthe counting of doses dispensed from the container, or the counting ofthe number of doses remaining therein. For example, a key member havinga key portion with a thickness of 1 mm and an inner diameter of 13 mm isprevented from being installed in a passageway having a width of 1 mmand an inner diameter of 15 mm, and vice versa.

It should be understood that the mating key member and key entrypassageway can also be used with various delivery systems that do notinclude an indicating device, as explained above. Often, deliverysystems can be configured to deliver a specific type of substance.Because a differently configured delivery system may not maximize thedelivery of the intended substance, such as a medicament, it may beimportant to ensure that a specific delivery system is used with aparticular substance. In this way, a mating key member and key entrypassageway can be mounted on one or the other of the container andhousing, or similar structure, of the delivery system so as to ensurethat the proper container is installed in the proper delivery system.

In the alternative embodiment of FIG. 25, the module housing includesthree pairs of upstanding members 1080, 1082 forming a slot or recess1084 between each pair. In addition, the upstanding members of one pair1082 are formed as channels opening towards each other. The elongatedrecess 1056 formed between the pair of members is shaped to receive theupper portion of the actuator member 574. In operation, the key portion1308 of the key member is shaped to be received in the various radiallyformed slots or recesses, or key entry passageways, so as to engage theactuator member disposed in the elongated recess. When the container ismoved with respect to the module housing so as to move the valve to theopen position, the hub of the container nests in a recess formed betweenthe inner upstanding member of each pair.

In the embodiment shown in FIGS. 32 and 33, three sets of threeupstanding members 1180, 1182 are provided, with each set of threehaving two slots 1184 formed between the members so as to be shaped toreceive the two key portions 1508 of the key member 1500. Again, one setof three members 1182 forms an elongated passageway, or recess 1056,that is shaped to receive the actuator member. The two key portionconfiguration allows for multiple combinations of shapes and diametersof key portions so as to provide for a different key combination foreach of the multiplicity of substances being dispensed from the variouscontainers.

Although the circular configurations of the key portion andcorresponding slots shaped to receive the key portion, as shown in thefigures, are preferred since they allow the container to be rotatedwithin the dispenser housing about its longitudinal axis, it should beunderstood that the key portion and slot, or like passageway or keyhole,can be shaped in any type of mating configuration and that the matingshapes are not limited to the circular configuration shown in thefigures.

The indicator module provides an inexpensive and accurate device forcounting dosages of medicament and the like. The module can be sized foreasy installation as a separate unit in most conventional inhalationhousings with minimal modification of the housing, including providing aviewing window in the housing in alignment with the module viewingwindow and the removal of any structure formed between the support blockand outer wall of the housing. In addition, the module can be installedrearwardly of the support block so as not to interfere with or otherwiseimpede the air flow dispensing the medicament.

Although the present invention has been described with reference topreferred embodiments, those skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. As such, it is intended that the foregoingdetailed description be regarded as illustrative rather than limitingand that it is the appended claims, including all equivalents thereof,which are intended to define the scope of the invention.

What is claimed is:
 1. An indicating device for a dispenser thatdispenses metered dosages of a substance from a container having a valvemoveable between a closed position and an open position, said containerdispensing said metered dosage when said valve is moved to the openposition, said indicating device comprising:a housing comprising atleast one engagement member; a plurality of indicator members coaxiallymounted in said housing and comprising at least a first and secondindicator member, at least one of said first and second indicatormembers having dosage indicia, at least one of said first and secondindicator members comprising an advancement member and at least theother of said first and second indicator members comprising a pluralityof teeth, wherein said engagement member is selectively engaged withsaid advancement member, wherein said engagement member biases saidadvancement member into operable engagement with at least one of saidplurality of teeth of said at least the other of said first and secondindicator members as said first indicator member is rotated relative tosaid second indicator member, whereby said advancement member causessaid second indicator member to rotate an incremental amount.
 2. Theinvention of claim 1 further comprising an actuator member mounted insaid housing and responsive to said movement of said valve, and whereinsaid first indicator member comprises a plurality of teeth, saidactuator member adapted to selectively engage at least one of saidplurality of teeth on said first indicator member so as to advance saidfirst indicator member an incremental amount in response to saidmovement of said valve.
 3. The invention of claim 2 further comprising aspring disposed in said housing and adapted to bias said actuator memberinto engagement with said container.
 4. The invention of claim 1 furthercomprising a third indicator member coaxially mounted in said housingwith said first and second indicator members, wherein at least one ofsaid second and third indicator members comprises a second advancementmember and at least the other of said second and third indicator memberscomprises a plurality of teeth, and said housing further comprising atleast a second engagement member, wherein said second engagement memberis selectively engaged with said second advancement member, wherein saidsecond engagement member biases said second advancement member intooperable engagement with at least one of said plurality of teeth of saidat least said other of said second and third indicator members as saidsecond indicator member is rotated relative to said third indicatormember, whereby said advancement member causes said third indicatormember to rotate an incremental amount.
 5. The invention of claim 1wherein said housing further comprises at least one non-return memberselectively engaged with at least one of said plurality of said teeth ofat least one of said plurality of indicator members.
 6. The invention ofclaim 5 wherein said engagement member and said non-return member areintegrally formed as a single member.
 7. The invention of claim 1wherein said engagement member comprises a ramped surface.
 8. Theinvention of claim 1 wherein said engagement member comprises aresilient arm member extending from said housing.
 9. The invention ofclaim 1 wherein said housing comprises a first housing disposed in asecond housing, wherein said plurality of indicator members are mountedin said first housing and wherein said second housing is adapted tosupport said container .
 10. The invention of claim 1 wherein saidhousing comprises a dispenser housing adapted to support said container.11. The invention of claim 1 wherein said housing comprises a viewingwindow, said indicia exposed to the user in said viewing window.
 12. Theinvention of claim 1 wherein at least one of said indicator memberscomprises an indicator wheel having a circumferential surface, saiddosage indicia applied to said circumferential surface.
 13. Theinvention of claim 12 wherein said at least one of said plurality ofindicator members further comprises a ratchet gear coaxially mountedwith said indicator wheel and attached thereto, said ratchet gearcomprising said plurality of teeth.
 14. The invention of claim 1 whereinat least one of said indicator members comprises an indicator wheelhaving a circumferential skirt.
 15. The invention of claim 14 whereinsaid advancement member is formed from a portion of said circumferentialskirt.
 16. The invention of claim 14 wherein said advancement member isdisposed radially inward from said circumferential skirt.
 17. Theinvention of claim 1 wherein said advancement member includes a toothportion adapted to engage said at least one of said plurality of teethof said adjacent indicator member.
 18. The invention of claim 1 furthercomprising a key member having a key portion, said key member adapted tobe mounted to said container, and wherein said housing comprises apassageway shaped to receive said key portion.
 19. An indicator moduleadapted to be received within a dispenser housing, said indicator modulecomprising:a module housing dimensioned to be received within saiddispenser housing; and a plurality of indicator members rotatably andcoaxially mounted in said module housing, each of said indicator memberscomprising dosage indicia.
 20. The invention of claim 19 furthercomprising an actuator member adapted to engage a container having avalve moveable between a closed position and an open position, saidcontainer dispensing a metered dosage of medicament when said valve ismoved to the open position, said actuator member moveable within saidmodule housing and selectively engaged with at least one of saidindicator members to move said at least one indicator member in responseto the movement of said valve.
 21. The invention of claim 20 furthercomprising a spring disposed within said module housing and engagingsaid actuator member so as to bias said actuator member upwardly withinsaid module housing.
 22. The invention of claim 19 wherein said modulehousing comprises a first and second member joined to form an enclosure.23. The invention of claim 19 further comprising a viewing window formedin said module housing.
 24. The invention of claim 19 wherein saidmodule housing has a key entry passageway formed therein, and furthercomprising a key member having a key portion, wherein said key portionis received in said key entry passageway.
 25. The invention of claim 19wherein said plurality of indicator members comprises at least a firstand second indicator member, wherein at least one of said first andsecond indicator members comprises an advancement member and at leastthe other of said first and second indicator members comprises aplurality of teeth, and wherein said module housing comprises anengagement member, wherein said engagement member is selectively engagedwith and biases said advancement member into operable engagement with atleast one of said plurality of teeth of said other of said first andsecond indicator member as said first indicator member is rotatedrelative to said second indicator member.
 26. The invention of claim 25further comprising a third indicator member coaxially mounted in saidmodule housing with said first and second indicator members, wherein atleast one of said second and third indicator members comprises anadvancement member and at least the other of said second and thirdindicator members comprises a plurality of teeth, and said modulehousing further comprising at least a second engagement member, whereinsaid second engagement member is selectively engaged with and biasessaid advancement member of said at least one of said second and thirdindicator members into operable engagement with at least one of saidplurality of teeth of said other of said second and third indicatormembers as said second indicator member is rotated relative to saidthird indicator member, whereby said advancement member causes saidthird indicator member to rotate an incremental amount.
 27. Theinvention of claim 25 wherein said module housing further comprises atleast one non-return member selectively engaged with at least one ofsaid plurality of teeth of said at least said other of said plurality ofindicator members.
 28. The invention of claim 27 wherein said engagementmember and said non-return member are integrally formed as a singlemember.
 29. The invention of claim 25 wherein said engagement membercomprises a ramped surface.
 30. The invention of claim 25 wherein saidengagement member comprises a resilient arm member extending from saidmodule housing.
 31. The invention of claim 25 wherein at least one ofsaid indicator members comprises an indicator wheel having acircumferential skirt, wherein said advancement member is formed from aportion of said circumferential skirt.
 32. The invention of claim 31wherein said advancement member is disposed radially inward from saidcircumferential skirt.
 33. An indicating device for a dispenser thatdispenses metered dosages of a medicament from a container having avalve moveable between a closed position and an open position, saidcontainer dispensing said metered dosage when said valve is moved to theopen position, said indicating device comprising:a housing; a pluralityof indicator members coaxially mounted in said housing and comprising atleast a first and second indicator member; and means for advancing saidsecond indicator member relative to said first indicator member.
 34. Theinvention of claim 33 wherein said housing is adapted to moveablysupport said container, and further comprising means for advancing saidfirst indicator member in response to the movement of said containerrelative to said housing.
 35. The invention of claim 33 wherein saidmeans for advancing is disposed in an indicator module, said indicatormodule disposed in said housing.
 36. An indicating device for adispensing device that dispenses metered dosages of a medicament from acontainer having a valve stem extending longitudinally therefrom andmoveable between a closed position and an open position, said containerdispensing said metered dosage when said valve stem is moved to the openposition, said indicating device comprising:a housing adapted to moverelative to said container as said container is moved between said openand closed positions; a plurality of indicator members coaxially androtatably mounted in said housing, each of said indicator memberscomprising indicia applied to a circumferential surface thereof andvisible to the user, said plurality of indicator members selectively andoperably connected such that successive movements of said containerrelative to said housing causes at least one of said indicator membersto rotate, whereby said indicia visible to the user is changed toindicate the dispensing of at least one metered dosage.
 37. Theinvention of claim 36 wherein said housing comprises a module housingdisposed in a dispenser housing, said dispenser housing adapted tomoveably support the container.
 38. The invention of claim 36 whereinsaid housing comprises a dispenser housing adapted to support thecontainer.
 39. The invention of claim 36 wherein said plurality ofindicator members comprises at least a first and second indicatormember, said first indicator member selectively and operably engagedwith said second indicator member upon successive rotations of saidfirst indicator member so as to rotate said second indicator member anincremental amount for each successive rotation of said first indicatormember.
 40. The invention of claim 39 further comprising an actuatormember operably engaged with said container, wherein said actuatormember rotates said first indicator member an incremental amount inresponse to said movement of said container relative to said housing.41. A dispenser for dispensing metered dosages of a substance from acontainer having a valve moveable between a closed position and an openposition, said container dispensing said metered dosage when said valveis moved to the open position, said dispenser comprising:a dispenserhousing shaped to receive the container; an indicator housing disposedin said dispenser housing, said indicator housing comprising at leastone engagement member; a plurality of indicator members coaxiallymounted in said indicator housing and comprising at least a first andsecond indicator member, said first and second indicator memberscomprising dosage indicia, said first indicator member comprising anadvancement member and said second indicator member comprising aplurality of teeth, said engagement member intermittently engaged withsaid advancement member, wherein said engagement member biases saidadvancement member into operable engagement with at least one of saidplurality of teeth on said second indicator member as said firstindicator member is rotated relative to said second indicator member.42. The invention of claim 41 wherein said first indicator membercomprises a plurality of teeth and further comprising an actuator membermoveably mounted to said indicator housing, said actuator memberselectively engaged with at least one of said plurality of teeth on saidfirst indicator member.
 43. The invention of claim 41 wherein saidplurality of indicator members further comprises a third indicatormember coaxially mounted with said first and second indicator members insaid indicator housing, said third indicator member comprising aplurality of teeth, and wherein said second indicator member comprises asecond advancement member, and wherein said indicator housing furthercomprises a second engagement member, said second engagement memberintermittently engaged with said second advancement member, wherein saidsecond engagement member biases said second advancement member intooperable engagement with at least one of said plurality of teeth on saidthird indicator member as said second indicator member is rotatedrelative to said third indicator member.
 44. The invention of claim 41wherein said first and second indicator members comprise indicatorwheels, and wherein said advancement member comprises a curved resilientportion terminating in an end portion, wherein said end portion operablyengages at least one of said plurality of teeth on said second indicatorwheel.
 45. The invention of claim 41 wherein said engagement membercomprises a ramped surface.
 46. The invention of claim 41 wherein saidengagement member comprises a resilient member extending from saidindicator housing.
 47. The invention of claim 41 wherein said engagementmember further defines a non-return member selectively engaged with atleast one of said plurality of teeth of said second indicator member.48. The invention of claim 41 wherein said dispenser housing has acavity and comprises a top portion having an opening dimensioned toreceive said container and a bottom portion comprising an exhaust port,wherein said opening provides access to said cavity, and wherein saidindicator housing is disposed in said cavity in said bottom portion ofsaid dispenser housing.
 49. The invention of claim 48 wherein saidbottom portion further comprises a support block extending upwardly intosaid cavity, wherein said support block comprises an orifice in flowcommunication with said exhaust port, wherein said module housing isdisposed in said cavity adjacent said support block without blockingsaid orifice.
 50. A dispenser for dispensing metered dosages of asubstance from a container having a valve moveable between a closedposition and an open position, said container dispensing said metereddosage when said valve is moved to the open position, said dispensercomprising:a dispenser housing comprising a bottom, a top, a walldefining a longitudinally extending cavity open at said top, and asupport block extending from said bottom into said cavity, wherein saidsupport block is spaced from said wall; an indicator housing at least aportion of which is disposed in said cavity between said support blockand said wall; and a plurality of indicator members coaxially mounted insaid indicator housing and comprising at least a first and secondindicator member, said first and second indicator members comprisingdosage indicia.
 51. The invention of claim 50 wherein said indicatorhousing comprises at least one engagement member and wherein said firstindicator member comprises an advancement member and said secondindicator member comprises a plurality of teeth, said engagement memberintermittently engaged with said advancement member, wherein saidengagement member biases said advancement member into operableengagement with at least one of said plurality of teeth on said secondindicator member as said first indicator member is rotated relative tosaid second indicator member.
 52. The invention of claim 51 wherein saidfirst indicator member comprises a plurality of teeth and furthercomprising an actuator member moveably mounted to said indicatorhousing, said actuator member selectively engaged with at least one ofsaid plurality of teeth on said first indicator member.
 53. Theinvention of claim 51 wherein said plurality of indicator membersfurther comprises a third indicator member coaxially mounted with saidfirst and second indicator members in said indicator housing, said thirdindicator member comprising a plurality of teeth, and wherein saidsecond indicator member comprises a second advancement member, andwherein said indicator housing further comprises a second engagementmember, said second engagement member intermittently engaged with saidsecond advancement member, wherein said second engagement member biasessaid second advancement member into operable engagement with at leastone of said plurality of teeth on said third indicator member as saidsecond indicator member is rotated relative to said third indicatormember.
 54. The invention of claim 51 wherein said first and secondindicator members comprise indicator wheels, and wherein saidadvancement member comprises a curved resilient portion terminating inan end portion, wherein said end portion operably engages at least oneof said plurality of teeth on said second indicator wheel.
 55. Theinvention of claim 51 wherein said engagement member comprises a rampedsurface.
 56. The invention of claim 51 wherein said engagement membercomprises a resilient member extending from said indicator housing. 57.The invention of claim 51 wherein said engagement member further definesa non-return member selectively engaged with at least one of saidplurality of teeth of said second indicator member.
 58. The invention ofclaim 50 wherein said module housing comprises a first and second memberconnected to form an enclosure.